A Phase I, Open-label Trial of Belzupacap Sarotalocan (AU-011) to Determine the Feasibility and Safety of Intratumoral Injection With or Without Intramural Injection in Subjects With Bladder Cancer

Study Identifier:
AU-011-102
CT.gov Identifier:
NCT05483868
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Study Complete

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Study Summary

To evaluate AU-011 as a single agent and as a combination therapy in patients with non-muscle invasive bladder cancer

To evaluate the safety and early proof of mechanism, assess distribution, local necrosis and evidence of immune activation

To evaluate the incidence of AU-011 treatment-related adverse events, serious adverse events (SAEs) and dose-limiting toxicities (DLTs)

To determine the feasibility of AU-011 treatment of non-muscle invasive bladder cancer utilizing intramural with or without intratumoral injection

To assess the safety and tolerability of belzupacap sarotalocan as a single agent.

The main objectives of this study are to determine the feasibility and safety of Belzupacap Sarotalocan (AU-011, bel-sar) treatment of bladder cancer utilizing focal injections with or without laser application.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Focal injections of AU-011 prior to TURBT (1b)
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  • Drug: Experimental: Focal injections of AU-011 with laser application before TURBT (4a)
  • Drug: Experimental: Focal injection of AU-011 with laser application before TURBT (4b)
  • Drug: Experimental: Focal injection of AU-011 with laser application before TURBT (4c)
  • Drug: Experimental: Focal injection of AU-011 and laser application with option for TURBT (4d)
  • Drug: Experimental: Focal injection of AU-011 and laser application with option for TURBT (4e)
  • Drug: Experimental: Focal injection of AU-011 and laser application with mandatory TURBT (4f)
  • Drug: Experimental: Focal injection of AU-011 and laser application with optional TURBT (4g)
  • Drug: Experimental: Focal injection of AU-011 and laser application with option for TURBT (4h)
  • Drug: Experimental: Focal injection of AU-011 and laser application with mandatory TURBT (4i)
  • Drug: All patients that received bel-sar without light activation (n=5) had intermediate-risk NMIBC, and no patients had a clinical complete response or tumor shrinkage after treatment. In NMIBC patients that received bel-sar with light activation (n=10),
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Study Complete

    Requirements information
    Inclusion criteria
    • Meet the following histopathologic requirements for urothelial carcinoma:
    • For Cohorts 1b, 4a-c:
    • histopathological diagnosis of NMIBC (any grade) is required. For participants with first diagnosis of NMIBC, confirmation of urothelial carcinoma by recent biopsy (≤6 months of Screening Visit) is required. Participants with recurrent NMIBC must have a current lesion that clinically appears to be NMIBC with histopathologic confirmation based on TURBT or biopsy within the last 24 months).
    • For Cohorts 4d, 4e, 4g and 4h, a diagnosis of LG IR NMIBC (according to
    • AUA risk classification guidelines) is required, specifically:
    • Multifocal LG Ta; OR
    • Solitary LG Ta >3 cm; OR
    • Low-grade Ta with prior recurrence(s) within 1 year.
    • For Cohorts 4f and 4i, a diagnosis of HR NMIBC (according to AUA risk classification guidelines) is required, specifically:
    • Ta HG papillary disease with or without CIS; OR
    • T1 papillary disease with or without CIS
    • Participants may be BCG-naïve or may have received prior treatment with BCG for HR or IR NMIBC (BCG-exposed, BCG-failed, BCG-intolerant)
    • BCG-refractory participants are excluded. BCG-refractory is defined by the following:
    • Persistent HG disease at 6 months following adequate BCG (defined as ≥5/6 induction instillations and ≥2 additional doses, either from re-induction or maintenance), OR
    • HG T1 disease at first evaluation (3 months) after BCG, OR
    • Persistent CIS that remains despite a second BCG course, OR
    • Disease progression in stage or grade during BCG therapy, including maintenance
    • Have no evidence of current or prior metastatic urothelial carcinoma
    • Adequate bone marrow, renal, and hepatic function
    Exclusion criteria
    • Any additional malignancy that requires active treatment, unless deemed appropriate after discussion by the Investigator with the trial's Medical Monitor.
    • Used an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) of Visit 1 or be concurrently enrolled in another investigational trial.
    • Active bacterial, fungal, or viral infections - all prior infections must have resolved following optimal therapy and subject must be off all systemic anti-infective agents.
    • Active autoimmune disease, chronic inflammatory condition, or other conditions (like solid organ transplant or bone marrow allograft) requiring concurrent use of any systemic immunosuppressants or steroids.
    • Chronic active hepatitis B or C and HIV.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruiting
    Condition(s) Treated at Site
    Bladder
    Urinary tract